Product quality issues that led to a nearly two-year delay in approval of CellTrans, Inc.’s Lantidra (donislecel-jujn) for type 1 diabetes reflect the challenges small sponsors of novel and complex biological therapies face in getting their manufacturing programs ready to satisfy regulatory expectations.
Lantidra’s First-Cycle Complete Response Letter Centered On Inspection And Product Quality Issues
Although the CRL delayed the cell therapy’s approval by almost two years, additional CMC-related testing requested by the FDA ultimately came to be seen as a good thing by sponsor CellTrans because it provided assurance of product consistency.
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